Cardio Rep CK Calibrators 1 & 2 Cat. No. 3322 & 3323
FDA 510(k) K932768 · Helena Laboratories
510(k) numberK932768
Submission
- Device name
- Cardio Rep CK Calibrators 1 & 2 Cat. No. 3322 & 3323
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- June 8, 1993
- Decision date
- October 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K141388 | System CalibraterJIX · Abbreviated | Beckman Coulter Ireland, Inc. | 07/11/2014SE |
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| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | Elitechgroup | 04/04/2013SE |
| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
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Questions and answers
When was Cardio Rep CK Calibrators 1 & 2 Cat. No. 3322 & 3323 cleared by the FDA?
Cardio Rep CK Calibrators 1 & 2 Cat. No. 3322 & 3323 (K932768) received a 510(k) decision of Substantially Equivalent on October 18, 1993, 132 days after the submission was received.
What is the product code of K932768?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.